Although conventional percutaneous transluminal coronary angioplasty (PTCA) procedures have been somewhat effective in treating coronary artery disease, cutting balloons are currently viewed by many as the next generation treatment option for the revascularization of both coronary and peripheral vessels. The cutting balloon mechanism is unique in that the balloon pressure is distributed over one or more incising elements (e.g. microtomes). The incising elements function as stress concentrators and cut initiators in PTCA atherectomy procedures. Consequently, PTCA atherectomy procedures have been proven to minimize vessel recoil, lessen vessel injury and lower the rate of restenosis, as compared to conventional PTCA procedures.
The incising elements used in cutting balloons include an operative surface feature (e.g. edge) that is capable of incising tissue. In the absence of suitable precautions, the incising elements can tear, cut or perforate the thin, fragile inflation balloon during assembly of the cutting balloon, handling or during clinical use. In a worst case, a balloon perforation or tear can result in an unsuccessful PTCA atherectomy procedure and the loss of inflation fluid into the patient's vasculature. In addition to balloon perforation concerns, another consideration involves the prevention of an inadvertent or unwanted cutting or incising of tissue as the cutting balloon is either being advanced into or withdrawn from the vasculature.
Along these lines, a device having a parting edge which is shielded within the pleats of an expandable clover leaf shaped tube is disclosed by Shiber in U.S. patent application Publication No. US 2002/0151924, filed Oct. 17, 2002 and entitled “Clover Leaf Shaped Tubular Medical Device”. However, the clover leaf design disclosed by Shiber does not necessarily protect the relatively fragile balloon during installation of the parting edges on the clover leaf balloon. In addition, because the parting edges are located within the pleats of the balloon, portions of the balloon may be exposed to the parting edges when the device is twisted, turned and bent through the curved vasculature of a patient.
In light of the above, it is an object of the present invention to provide a protective sheath for an incising element mounted on an inflatable balloon which compresses to expose the incising element during balloon inflation at a treatment site. Another object of the present invention is to provide a protective sheath for an incising element mounted on an inflatable balloon that protects the incising element from inadvertently cutting tissue as the deflated balloon is maneuvered through the vasculature of a patent. Still another object of the present invention is to provide a protective sheath for an incising element mounted on an inflatable balloon that is easy to use, relatively simple to manufacture and comparatively cost effective.